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NCT01970865 · OUTCOME

Time for Cmax (Tmax) of Midazolam (Phase 1)

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15

What was measured

Tmax of midazolam was observed directly from data as time of first occurrence. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.

Analysis population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.

Groups in this outcome

25 mg QD (Phase 1)

PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

150 mg QD (Phase 1)

PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
25 mg QD (Phase 1)3
150 mg QD (Phase 1)3

Reported measurements

Day -7
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
25 mg QD (Phase 1)0.50Not reported0.501.00Not reported
150 mg QD (Phase 1)0.50Not reported0.500.50Not reported
Cycle 1 Day 15
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
25 mg QD (Phase 1)0.50Not reported0.501.00Not reported
150 mg QD (Phase 1)0.50Not reported0.500.533Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.50
        upper Limit
        1.00
        value
        0.50
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        0.50
        value
        0.50
    title
    Day -7
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.50
        upper Limit
        1.00
        value
        0.50
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        0.533
        value
        0.50
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Tmax of midazolam was observed directly from data as time of first occurrence. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
dispersion Type
Full Range
groups
  1. description
    PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
    id
    OG000
    title
    25 mg QD (Phase 1)
  2. description
    PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
    id
    OG001
    title
    150 mg QD (Phase 1)
param Type
MEDIAN
population Description
PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
reporting Status
POSTED
time Frame
Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15
title
Time for Cmax (Tmax) of Midazolam (Phase 1)
type
SECONDARY
unit Of Measure
Hours

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice